A study of the effects of the FertilMate - a Scrotal COoling Patch on male fertility (SCOP)
| ISRCTN | ISRCTN94041896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94041896 |
| Secondary identifying numbers | EM 11024 |
- Submission date
- 15/07/2011
- Registration date
- 29/09/2011
- Last edited
- 22/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The testes are housed in the scrotum because the scrotum is a few degrees cooler than the core body temperature, which forms the best environment for sperm production. This study aims to find out whether exposing the scrotum to lower temperatures using a cooling patch improves the fertility of men who have abnormal sperm counts.
Who can participate?
Any man above the age of 18 who has an abnormal sperm count.
What does the study involve?
Participants are randomly allocated to one of two groups. Men in one group wear the cooling patch for 8 hours per day for a period of 90 consecutive days. Men in the other group do not wear the patch. In order to determine if there is an improvement we test the participants’ sperm count at the start and the end of the study.
What are the possible benefits and risks of participating?
To date we do not know of any risks as the cooling patch has been tested and proven to be safe.
Where is the study run from?
Nottingham University Hospitals (UK).
When is the study starting and how long is it expected to run for?
August 2011 to May 2012.
Who is funding the study?
University of Nottingham (UK).
Who is the main contact?
Mr William Atiomo (william.atiomo@nottingham.ac.uk)
Dr Ilias Nikolopoulos (illias.nikolopolous@nuh.nhs.uk)
Dr Waseem Osman (Mohammed.Osman@nuh.nhs.uk)
Contact information
Scientific
Nottingham University Hospitals
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Randomised control trial pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pilot randomised study of the effects of the FertilMate - a scrotal cooling patch on male fertility |
| Study acronym | SCOP |
| Study objectives | To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility. |
| Ethics approval(s) | NRES Committee East Midlands - Nottingham 2, 27/05/2011, ref: 11/EM/0163 |
| Health condition(s) or problem(s) studied | Reproductive medicine |
| Intervention | 1. Scrotal cooling patch worn by the study group 2. Semen analyses on all 40 participants on day 0 and day 90 3. Serum metabolomics tested by means of 1x 20ml blood sample |
| Intervention type | Other |
| Primary outcome measure | 1. To determine whether exposing the scrotum to lower temperatures by means of a scrotal cooling patch may improve fertility 2. The main parameter will be a change to sperm count, quality and concentration 3. Improvements to sperm motility and morphology |
| Secondary outcome measures | Scrotal bloodflow |
| Overall study start date | 01/08/2011 |
| Completion date | 01/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 40, 20 in the study group and 20 in the control group |
| Key inclusion criteria | 1. Males 2. Aged 18 to 45 years of age |
| Key exclusion criteria | 1. Candidates who have undergone a vasectomy 2. Candidates who have an allergy to menthol 3. Males aged below 18 and older than 45 years on age 4. We will not be recruiting individuals that are unable to consent for themselves and nor will we be including participants who are from vulnerable groups |
| Date of first enrolment | 01/08/2011 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NG7 2UH
United Kingdom
Sponsor information
University/education
c/o Mr Paul Cartledge
University of Nottingham
University Park
Nottingham
NG7 2 RD
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/04/2012 | Yes | No |
Editorial Notes
22/11/2018: No publications found, verifying study status with principal investigator.
